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Sequenom v. Ariosa Diagnostics: A Supreme Court Petition that Requests Clarification on the Patent Eligibility of Diagnostic Methods

Posted in Development & Commercialization of Technology, Intellectual Property, Patent Counseling & Strategies, Patent Law, Patent Prosecution

Under the Patent Act, one can patent “any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof.”[1] Common exceptions to what can be patented include laws of nature, natural phenomena, and abstract ideas[2].  In Ariosa Diagnostics, Inc. v. Sequenom, Inc. (Sequenom), the United States Court of Appeals for the Federal Circuit held that a patent covering methods of detecting cell-free fetal DNA is not eligible for patenting because it pertains to nothing more than a natural phenomenon[3].  The patent at issue in Sequenom pertained to a method of detecting cell-free fetal DNA (cffDNA), a non-cellular DNA that floats freely in the blood stream of pregnant women[4].  The detection methods involved amplifying segments of the cffDNA by various methods, such as the polymerase chain reaction[5].

In reaching its decision, the Court reasoned that the patent at issue is not eligible for patenting because it “starts and ends with a naturally occurring phenomenon”[6] (i.e., cffDNA).  Moreover, the Court reasoned that the cffDNA amplification step did not make the invention eligible subject matter because the amplification methods were “conventional, routine and well understood applications in the art.”[7]  In particular, the Court indicated that, “[b]ecause the method steps were well-understood, conventional and routine, the method of detecting …cffDNA is not new and useful.”[8]  The Court also stated that “appending routine, conventional steps to a natural phenomenon, specified at a high level of generality, is not enough to supply an inventive concept.”[9]

In response to the Court’s ruling (and a subsequent upholding of the ruling in an en banc decision by the same Court), Sequenom, Inc. filed a Petition for Writ of Certiorari in the U.S. Supreme Court[10].  In the Petition, Sequenom has asked the Supreme Court to consider “whether a novel method is patent-eligible where: (1) a researcher is the first to discover a natural phenomenon; (2) that unique knowledge motivates him to apply a new combination of known techniques to that discovery; and (3) he thereby achieves a previously impossible result without preempting other uses of the discovery.”[11]

Many have identified a lack of clarity on the aforementioned issue as a “crisis of patent law and medical innovation.”[12]  Moreover, different opinions exist on when an application of a natural phenomenon can be eligible for patenting.  For instance, in its Petition, Sequenom has asserted that “new methods assembled by combining previously known techniques even when those methods are motivated by or incorporate new insights into nature and its laws” are still eligible for patenting[13].  Therefore, if the Supreme Court grants Sequenom’s Petition, the Supreme Court’s subsequent ruling could provide more clarity on the above issue.

 

[1] 35 U.S.C. § 101

[2] Alice Corp. v. CLS Bank Int’l, 134 S. Ct. 2347, 2354 (2014)

[3] Ariosa Diagnostics, Inc. v. Sequenom, Inc., 2014-1139, 2014-1144, (Fed. Cir. 2015)

[4] Id. at page 3

[5] Id.

[6] Id. at page 13

[7] Id.

[8] Id. at page 11

[9] Id. at page 13

[10] Petition for a Writ of Certiorari, Sequenom, Inc. v. Ariosa Diagnostics, Inc., et al., Docket No. 15-1182, March 21, 2016

[11] Id. at page i

[12] Id. at page 15

[13] Id. at page 21